Early use of intrathecal baclofen in brain injury in pediatric patients.

BACKGROUND: The Food and Drug Administration (FDA) approved the use of intrathecal Baclofen for spasticity from traumatic brain injury in June of 1996 based on a Phase III clinical trial that documented efficacy in patients one year post injury. The FDA approval is only for patients who are one year post injury based on the Phase III study. We have found use of ITB in the first few months after injury very effective in a subgroup of severe traumatic brain injury (TBI) pediatric patients with spasticity, dystonia and autonomic storming following brain injury.
METHOD: The author's database of over 250 patients receiving intrathecal baclofen was reviewed. Retrospective chart review was undertaken of the 6 patients identified with brain injuries over a three year period that were given ITB less than one year post injury. The patients' diagnosis included asphyxia, traumatic brain injury and stroke. The ages were one year to fourteen years of age. ITB was offered after all conventional therapy had been exhausted and the patient's spasticity remained intractable. These patients also all experienced autonomic dysfunction with severe autonomic storms.
FINDINGS: All of the patients had a decrease in their spasticity of at least 2 points on the Ashworth score. The autonomic storms ceased in all 6 patients when adequate dosages of ITB were reached. The patients could be weaned from all oral and intravenous medications for tone, storming and fever. Many of the patients became much more alert and interactive when the medications were stopped. Five of the six are still using their pump for their tone one to five years post implant, the sixth had the pump stopped at the parents' request for religious reasons.
INTERPRETATION: Early use of ITB can play a significant role in the rehabilitation of brain injury in children.